Skip to main content
SpringerLink
Log in

Is balneotherapy effective for fibromyalgia? Results from a 6-month double-blind randomized clinical trial

  • Original Article
  • Published:
Clinical Rheumatology Aims and scope Submit manuscript

Abstract

The aim of this study was to assess the efficacy and tolerability of balneotherapy (BT) in patients with primary fibromyalgia syndrome (FS). In a prospective, randomized, controlled, double-blind trial with a 6-month follow-up, 100 FS patients were randomized to receive a cycle of BT with highly mineralized sulfate water (BT group) or with tap water (control group). Clinical assessments were performed at screening visit, at basal time, and after treatment (2 weeks, 3 and 6 months). The primary outcome measures were the change of global pain on the Visual Analogue Scale (VAS) and Fibromyalgia Impact Questionnaire total score (FIQ-Total) from baseline to 15 days. Secondary outcomes included Widespread Pain Index, Symptom Severity Scale Score, Short Form Health Survey, State-Trait Anxiety Inventory (STAI), and Center for Epidemiologic Studies Depression Scale. We performed an intent-to-treat analysis. The Kolmogorov-Smirnov test was applied to verify the normality distribution of all quantitative variables and the Student’s t test to compare sample data. In the BT group, we observed a significant improvement of VAS and FIQ-Total at the end of the treatment that persisted until 6 months, while no significant differences were found in the control group. The differences between groups were significant for primary parameters at each time point. Similar results were obtained for the other secondary outcomes except for the STAI outcome. Adverse events were reported by 10 patients in the BT group and by 22 patients in the control group. Our results support the short- and long-term therapeutic efficacy of BT in FS. Trial registration: NCT02548065

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Subscribe and save

Springer+ Basic
$34.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or eBook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Mease P (2005) Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures and treatment. J Rheumatol Suppl 75:6–21

    PubMed  Google Scholar 

  2. Wolfe F, Brahler E, Hinz A, Häuser W (2013) Fibromyalgia prevalence, somatic symptom reporting, and the dimensionality of polysymptomatic distress: results from a survey of the general population. Arthritis Care Res 65:777–785. https://doi.org/10.1002/acr.21931

    Article  Google Scholar 

  3. Spaeth M (2009) Epidemiology, costs, and the economic burden of fibromyalgia. Arthritis Res Ther 11:117. https://doi.org/10.1186/ar2715

    Article  PubMed  PubMed Central  Google Scholar 

  4. Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser W, Fluß E et al (2017) EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis 76:318–328. https://doi.org/10.1136/annrheumdis-2016-209724

    Article  PubMed  CAS  Google Scholar 

  5. Goldenberg DL, Burckhardt C, Crofford L (2004) Management of fibromyalgia syndrome. JAMA 292:2388–2395

    Article  PubMed  CAS  Google Scholar 

  6. Ablin J, Fitzcharles MA, Buskila D, Shir Y, Sommer C, Häuser W (2013) Treatment of fibromyalgia syndrome: recommendations of recent evidence-based interdisciplinary guidelines with special emphasis on complementary and alternative therapies. Evid Based Complement Alternat Med 2013:485272. https://doi.org/10.1155/2013/485272

    Article  PubMed  PubMed Central  Google Scholar 

  7. McVeigh JG, McGaughey H, Hall M, Kane P (2008) The effectiveness of hydrotherapy in the management of fibromyalgia syndrome: a systematic review. Rheumatol Int 29:119–130. https://doi.org/10.1007/s00296-008-0674-9

    Article  PubMed  Google Scholar 

  8. Langhorst J, Musial F, Klose P, Häuser W (2009) Efficacy of hydrotherapy in fibromyalgia syndrome—a meta-analysis of randomized controlled clinical trials. Rheumatology 48:1155–1159. https://doi.org/10.1093/rheumatology/kep182

    Article  PubMed  Google Scholar 

  9. Guidelli GM, Tenti S, De Nobili E, Fioravanti A (2012) Fibromyalgia syndrome and spa therapy: myth or reality? Clin Med Insights Arthritis Musculoskelet Disord 5:19–26. https://doi.org/10.4137/CMAMD.S8797

    Article  PubMed  PubMed Central  Google Scholar 

  10. Naumann J, Sadaghiani C (2014) Therapeutic benefit of balneotherapy and hydrotherapy in the management of fibromyalgia syndrome: a qualitative systematic review and meta-analysis of randomized controlled trials. Arthritis Res Ther 16:R141. https://doi.org/10.1186/ar4603

    Article  PubMed  PubMed Central  Google Scholar 

  11. Wolfe F, Clauw DJ, Fitzcharles M-A, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB (2010) The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res 62:600–610. https://doi.org/10.1002/acr.20140

    Article  Google Scholar 

  12. Burckhardt CS, Clark SR, Bennett RM (1991) The fibromyalgia impact questionnaire: development and validation. J Rheumatol 18:728–733

    PubMed  CAS  Google Scholar 

  13. Bennett R (2005) The Fibromyalgia Impact Questionnaire (FIQ): a review of its development, current version, operating characteristics and uses. Clin Exp Rheumatol 5(Suppl 39):S154–S162

    Google Scholar 

  14. Sarzi-Puttini P, Atzeni F, Fiorini T, Panni B, Randisi G, Turiel M, Carrabba M (2003) Validation of an Italian version of the Fibromyalgia Impact Questionnaire (FIQ-I). Clin Exp Rheumatol 21:459–464

    PubMed  CAS  Google Scholar 

  15. Apolone G, Mosconi P (1998) The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol 51:1025–1036

    Article  PubMed  CAS  Google Scholar 

  16. Ware J Jr, Kosinski M, Keller SD (1996) A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 34:220–233

    Article  PubMed  Google Scholar 

  17. Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA (1983) Manual for the state-trait anxiety inventory. Consulting Psychologists Press, Inc, Palo Alto

    Google Scholar 

  18. Lazzari R, Pancheri P (1980) Questionario di autovalutazione per l’ansia di stato e di tratto. Manuale di istruzioni. Ed. Organizzazioni Speciali, Firenze

  19. Radloff LS (1977) The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas 1:385–401

    Article  Google Scholar 

  20. Fava GA (1983) Assessing depressive symptoms across cultures: Italian validation of the CES-D self-rating scale. J Clin Psychol 39:249–251

    Article  PubMed  CAS  Google Scholar 

  21. Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL (2000) Defining the clinically important difference in pain outcome measures. Pain 88:287–294

    Article  PubMed  CAS  Google Scholar 

  22. Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB (2009) Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol 36:1304–1311. https://doi.org/10.3899/jrheum.081090

    Article  PubMed  Google Scholar 

  23. Fraioli A, Grassi M, Mennuni G, Geraci A, Petraccia L, Fontana M, Conte S, Serio A (2013) Clinical researches on the efficacy of spa therapy in fibromyalgia. A systematic review. Ann Ist Super Sanita 49:219–229. https://doi.org/10.4415/ANN_13_02_13.

    Article  PubMed  Google Scholar 

  24. Neumann L, Sukenik S, Bolotin A, Abu-Shakra M, Amir M, Flusser D, Buskila D (2001) The effect of balneotherapy at the Dead Sea on the quality of life of patients with fibromyalgia syndrome. Clin Rheumatol 20:15–19

    Article  PubMed  CAS  Google Scholar 

  25. Buskila D, Abu-Shakra M, Neumann L, Odes L, Shneider E, Flusser D, Sukenik S (2001) Balneotherapy for fibromyalgia at the Dead Sea. Rheumatol Int 20:105–108

    Article  PubMed  CAS  Google Scholar 

  26. Evcik D, Kizilay B, Gökçen E (2002) The effects of balneotherapy on fibromyalgia patients. Rheumatol Int 22:56–59

    Article  PubMed  Google Scholar 

  27. Dönmez A, Karagülle MZ, Tercan N, Dinler M, Işsever H, Karagülle M et al (2005) SPA therapy in fibromyalgia: a randomised controlled clinic study. Rheumatol Int 26:168–172

    Article  PubMed  Google Scholar 

  28. Zijlstra TR, van de Laar MA, Bernelot Moens HJ, Taal E, Zakraoui L, Rasker JJ (2005) Spa treatment for primary fibromyalgia syndrome: a combination of thalassotherapy, exercise and patient education improves symptoms and quality of life. Rheumatology (Oxford) 44:539–546

    Article  CAS  Google Scholar 

  29. Fioravanti A, Perpignano G, Tirri G, Cardinale G, Gianniti C, Lanza CE, Loi A, Tirri E, Sfriso P, Cozzi F (2007) Effects of mud-bath treatment on fibromyalgia patients: a randomized clinical trial. Rheumatol Int 27:1157–1161

    Article  PubMed  Google Scholar 

  30. Ozkurt S, Dönmez A, Zeki Karagülle M, Uzunoğlu E, Turan M, Erdoğan N (2012) Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study. Rheumatol Int 32:1949–1954. https://doi.org/10.1007/s00296-011-1888-9

    Article  PubMed  Google Scholar 

  31. Bağdatlı AO, Donmez A, Eröksüz R, Bahadır G, Turan M, Erdoğan N (2015) Does addition of 'mud-pack and hot pool treatment' to patient education make a difference in fibromyalgia patients? A randomized controlled single blind study. Int J Biometeorol 59:1905–1911. https://doi.org/10.1007/s00484-015-0997-7

    Article  PubMed  Google Scholar 

  32. Koçyiğit BF, Gür A, Altındağ Ö, Akyol A, Gürsoy S (2016) Comparison of education and balneotherapy efficacy in patients with fibromyalgia syndrome: a randomized, controlled clinical study. Agri 28:72–78. https://doi.org/10.5505/agri.2015.77699

    Article  PubMed  Google Scholar 

  33. Tenti S, Fioravanti A, Guidelli GM, Pascarelli NA, Cheleschi S (2014) New evidence on mechanisms of action of spa therapy in rheumatic diseases. TANG 4:31–38

    Google Scholar 

  34. Cozzi F, Lazzarin P, Todesco S, Cima L (1995) Hypothalamic-pituitary-adrenal axis dysregulation in healthy subjects undergoing mud-bath applications. Arthritis Rheum 38:724–726

    Article  PubMed  CAS  Google Scholar 

  35. Morer C, Roques CF, Françon A, Forestier R, Maraver F (2017) The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials. Int J Biometeorol 61:2159–2173. https://doi.org/10.1007/s00484-017-1421-2

    Article  PubMed  Google Scholar 

  36. Bálint GP, Buchanan WW, Adám A, Ratkó I, Poór L, Bálint PV et al (2007) The effect of the thermal mineral water of Nagybaracska on patients with knee joint osteoarthritis—a double blind study. Clin Rheumatol 26:890–894

    Article  PubMed  Google Scholar 

  37. Kovács C, Pecze M, Tihanyi Á, Kovács L, Balogh S, Bender T (2012) The effect of sulphurous water in patients with osteoarthritis of hand. Double-blind, randomized, controlled follow-up study. Clin Rheumatol 31:1437–1442. https://doi.org/10.1007/s10067-012-2026-0

    Article  PubMed  Google Scholar 

  38. Kulisch A, Bender T, Németh A, Szekeres L (2009) Effect of thermal water and adjunctive electrotherapy on chronic low back pain: a double-blind, randomized, follow-up study. J Rehabil Med 41:73–79. https://doi.org/10.2340/16501977-0291

    Article  PubMed  Google Scholar 

  39. Karagülle M, Karagülle MZ (2015) Effectiveness of balneotherapy and spa therapy for the treatment of chronic low back pain: a review on latest evidence. Clin Rheumatol 34:207–214. https://doi.org/10.1007/s10067-014-2845-2

    Article  PubMed  Google Scholar 

  40. Prandelli C, Parola C, Buizza L, Delbarba A, Marziano M, Salvi V, Zacchi V, Memo M, Sozzani S, Calza S, Uberti D, Bosisio D (2013) Sulphurous thermal water increases the release of the anti-inflammatory cytokine IL-10 and modulates antioxidant enzyme activity. Int J Immunopathol Pharmacol 26:633–646

    Article  PubMed  CAS  Google Scholar 

  41. Bender T, Bariska J, Vághy R, Gomez R, Kovács I (2007) Effect of balneotherapy on the antioxidant system-a controlled pilot study. Arch Med Res 38:86–89

    Article  PubMed  CAS  Google Scholar 

  42. Cordero MD, Alcocer-Gómez E, Cano-García FJ, De Miguel M, Carrión AM, Navas P et al (2011) Clinical symptoms in fibromyalgia are better associated to lipid peroxidation levels in blood mononuclear cells rather than in plasma. PLoS One 6:e26915. https://doi.org/10.1371/journal.pone.0026915

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  43. Fatima G, Das SK, Mahdi AA (2017) Some oxidative and antioxidative parameters and their relationship with clinical symptoms in women with fibromyalgia syndrome. Int J Rheum Dis 20:39–45. https://doi.org/10.1111/1756-185X.12550

    Article  PubMed  CAS  Google Scholar 

  44. Ardiç F, Ozgen M, Aybek H, Rota S, Cubukçu D, Gökgöz A (2007) Effects of balneotherapy on serum IL-1, PGE2 and LTB4 levels in fibromyalgia patients. Rheumatol Int 27:441–446. https://doi.org/10.1007/s00296-006-0237-x

    Article  PubMed  CAS  Google Scholar 

  45. Sendur OF, Tastaban E, Turan Y, Ulman C (2008) The relationship between serum trace element levels and clinical parameters in patients with fibromyalgia. Rheumatol Int 28:1117–1121. https://doi.org/10.1007/s00296-008-0593-9

    Article  PubMed  CAS  Google Scholar 

  46. Mease PJ, Clauw DJ, Christensen R, Crofford LJ, Gendreau RM, Martin SA, OMERACT Fibromyalgia Working Group et al (2011) Toward development of a fibromyalgia responder index and disease activity score: OMERACT module update. J Rheumatol 38:1487–1495. https://doi.org/10.3899/jrheum.110277

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgements

The authors want to thank the Thermal Resort of Levico and Vetriolo, Levico Terme (Trento), Italy.

Funding

This study was supported by “Provincia Autonoma di Trento”. The sponsors of this study did not participate in the study design, in the collection, analysis, or the interpretation of data.

Author information

Authors and Affiliations

  1. Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Viale Bracci 1, 53100, Siena, Italy

    Antonella Fioravanti & Sara Tenti

  2. Thermal Resort of Levico and Vetriolo, Levico Terme, Trento, Italy

    Patrizia Manica

  3. Rheumatology Unit, S. Chiara Hospital, Trento, Italy

    Roberto Bortolotti & Giuseppe Paolazzi

  4. Department of Medical Biotechnologies, University of Siena, Siena, Italy

    Gabriele Cevenini

Authors
  1. Antonella Fioravanti
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Patrizia Manica
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Roberto Bortolotti
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Gabriele Cevenini
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Sara Tenti
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Giuseppe Paolazzi
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Sara Tenti.

Ethics declarations

Disclosures

None.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Fioravanti, A., Manica, P., Bortolotti, R. et al. Is balneotherapy effective for fibromyalgia? Results from a 6-month double-blind randomized clinical trial. Clin Rheumatol 37, 2203–2212 (2018). https://doi.org/10.1007/s10067-018-4117-z

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10067-018-4117-z

Keywords

Search

Navigation